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96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy
Date:7/20/2009

y 2009, an application was submitted to the FDA for traditional approval, which included 48-week data from DUET-1 and DUET-2.

INTELENCE, in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.

This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

The following points should be considered when initiating therapy with INTELENCE:

  • Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
  • The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
  • The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naive adults.

DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design and conducted across the Americas, Australia, Canada, Europe, Thailand and Europe, assessed the 24-week efficacy and safety of INTELENCE in combination with a BR in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. They were large randomized, controlled studies and the primary endpoint was the proportion of patients who achieved a confirmed undetectable viral load (less than 50 copies/mL).

Patients with HIV-1 who were eligibl
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SOURCE Tibotec Therapeutics
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